VSTM Up as NDA for Ovarian Cancer Combo Gets FDA's Priority Review Tag

Zacks01-02

Shares of Verastem Oncology VSTM rallied 40.9% on Tuesday after it announced that the FDA has accepted the new drug application (NDA) for its avutometinib/defactinib combo therapy to treat adult ...

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Avutometinib is an RAF/MEK clamp, while defactinib is a best-in-class selective FAK inhibitor.In the past three months, shares of Verastem have surged 86.6% against the industry’s 9.5% decline.More on the FDA Acceptance of Avutometinib NDA for LGSOC. At present, there are no FDA-approved treatments specifically for LGSOC, a rare and distinct type of ovarian cancer with unique biology and treatment responses compared to high-grade serous ovarian cancer, representing a huge unmet medical need. Per Verastem, an estimated 6,000-8,000 women in theUnited Statesand 80,000 worldwide suffer from this disease. The standard of care treatment includes hormone therapy and chemotherapy.Currently, the company is enrolling patients with recurrent LGSOC regardless of KRAS mutation status in the global phase III RAMP 301 study, which is expected to serve as a confirmatory study for the initial indica","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{},"translate_title":"VSTM作为卵巢癌组合的NDA获得FDA优先审查标签","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CSTL":1,"SPRO":1,"VSTM":1,"CTMX":0.9},"content_text":"Shares of Verastem Oncology VSTM rallied 40.9% on Tuesday after it announced that the FDA has accepted the new drug application (NDA) for its avutometinib/defactinib combo therapy to treat adult patients with recurrent low-grade serous ovarian cancer (LGSOC) for review under the accelerated approval pathway. The intended treatment population includes LGSOC patients who have received at least one prior systemic therapy and have a KRAS mutation.\nBoth avutometinib and defactinib have been in-licensed by Verastem from other pharmaceutical companies. Avutometinib is an RAF/MEK clamp, while defactinib is a best-in-class selective FAK inhibitor.\nThe FDA has granted the Priority Review status to the avutometinib/defactinib NDA filing for LGSOC. A filing accepted under the regulatory body’s Priority Review pathway reduces the review period to six months from the standard 10 months. This status is given to treatments that the FDA believes, could significantly improve existing options or provide solutions where no approved therapy exists. A final decision is expected on June 30, 2025. Per Verastem, the FDA has also stated that it does not plan to hold an advisory committee meeting to discuss the application.\nIn the past three months, shares of Verastem have surged 86.6% against the industry’s 9.5% decline.\nImage Source: Zacks Investment Research\nMore on the FDA Acceptance of Avutometinib NDA for LGSOC\nVerastem’s NDA filing is based on the primary analysis of the phase II RAMP 201 study that evaluated the combination of avutometinib and defactinib in patients with recurrent LGSOC. Per the data readout, treatment with the combo regimen resulted in a substantial overall response rate, confirmed by a blinded independent central review. Treatment responses were also typically durable. Additionally, the combo regimen was generally well-tolerated in patients with recurrent KRAS mutant LGSOC. The avutometinib NDA is also supported by data from the phase I FRAME study, the first study conducted with the avutometinib/defactinib combo therapy in recurrent LGSOC.\nAt present, there are no FDA-approved treatments specifically for LGSOC, a rare and distinct type of ovarian cancer with unique biology and treatment responses compared to high-grade serous ovarian cancer, representing a huge unmet medical need. Per Verastem, an estimated 6,000-8,000 women in the United States and 80,000 worldwide suffer from this disease. The standard of care treatment includes hormone therapy and chemotherapy.\nSubject to approval, the avutometinib/defactinib regimen will become the first-ever FDA-approved treatment specifically for adults with recurrent KRAS mutant LGSOC. Verastem is preparing for a potential commercial launch of the combo therapy in the United States in mid-2025.\nCurrently, the company is enrolling patients with recurrent LGSOC regardless of KRAS mutation status in the global phase III RAMP 301 study, which is expected to serve as a confirmatory study for the initial indication and has the potential to support an expanded indication regardless of KRAS mutation status.\nUnder its RAMP program, Verastem is conducting several clinical studies across various stages of development to evaluate avutometinib with and without defactinib for treating RAS/MAPK-driven tumors. Apart from the RAMP program, the company is also studying avutometinib and defactinib in combination with immunotherapeutic and other agents through investigator-sponsored trials for treating various solid tumors.\n\nVerastem, Inc. Price and Consensus\n\nVerastem, Inc. price-consensus-chart | Verastem, Inc. Quote\n\nVSTM’s Zacks Rank & Stocks to Consider\nVerastem currently carries a Zacks Rank #3 (Hold).\nSome better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO. While CSTL and SPRO sport a Zacks Rank #1 (Strong Buy) each, CTMX carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 60 days, 2024 estimates for Castle Biosciences have improved from a loss of 59 cents per share to earnings of 34 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.15 to $1.84. In the past three months, shares of Castle Biosciences have lost 6.2%.\nCSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.\nIn the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents during the same timeframe. In the past three months, Spero’s shares have lost 20.2%.\nSPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.\nIn the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 35 cents during the same timeframe. In the past three months, CTMX stock has lost 8.8%.\nCytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nVerastem, Inc. (VSTM) : Free Stock Analysis Report\nCytomX Therapeutics, Inc. (CTMX) : Free Stock Analysis Report\nSpero Therapeutics, Inc. (SPRO) : Free Stock Analysis Report\nCastle Biosciences, Inc. (CSTL) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.30.2","shortVersion":"4.30.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2500007971"}